Opportunity Information: Apply for PAR 21 354
The NIH funding opportunity PAR-21-354, titled "Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R03 - Clinical Trial Optional)," supports early-stage, small-scope research aimed at improving how serious conditions are identified and treated in newborns. The focus is on disorders that are already being found through newborn screening programs, as well as "high priority" genetic conditions that are not yet recommended for routine screening but could be feasible to screen for in the near future. A high priority condition, as defined in this announcement, is one where early detection would meaningfully change outcomes because infants would significantly benefit from prompt identification and early treatment, even though the condition is not currently on standard screening panels.
The main scientific goal is to encourage projects that either develop novel screening approaches or advance therapeutic interventions tied to newborn screening. On the screening side, this can include creating or refining tests that are more accurate, faster, more scalable for public health labs, or better at reducing false positives and false negatives. On the therapy side, the intent is to stimulate studies that strengthen the evidence that early intervention improves health outcomes, since showing a clear benefit from early detection and treatment is one of the key considerations when deciding whether a condition should be added to a newborn screening panel. In practice, this means the program is looking for work that helps close the gap between being able to detect a condition in a newborn and being able to demonstrate that acting on that information early actually prevents death, disability, or irreversible disease progression.
This is an R03 mechanism, which is typically used for pilot or feasibility research, proof-of-concept studies, and other discrete projects that can be completed with limited resources. The listed award ceiling is $50,000, signaling that the opportunity is geared toward focused, well-defined aims rather than large multi-year clinical development programs. The FOA is labeled "clinical trial optional," meaning applicants may propose a study that includes a clinical trial component if it fits the aims, but a clinical trial is not required to apply. The opportunity falls under NIH assistance listing (CFDA) 93.865 and is categorized as a discretionary grant within the health and social services activity area.
A wide range of organizations are eligible to apply, reflecting an interest in both research innovation and practical implementation across diverse settings. Eligible applicants include various levels of government (state, county, city/township, special districts), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized Native American tribal governments, and tribal organizations that are not federally recognized. Nonprofits are eligible whether or not they have 501(c)(3) status, and both for-profit organizations (other than small businesses) and small businesses may apply as well. The FOA also explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This broad eligibility suggests NIH is open to technical innovation from academic labs, public health systems, community-linked organizations, and international groups with relevant expertise.
Key logistics provided in the source information include an original closing date of 2024-11-16 and an opportunity creation date of 2021-11-09. While the summary information does not specify the expected number of awards, the emphasis on improving screening accuracy and building evidence for early-treatment benefit makes clear what NIH is trying to move forward: practical, testable advances that help more conditions meet the real-world criteria for newborn screening panels, namely reliable detection plus strong proof that early action improves infants' outcomes.Apply for PAR 21 354
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R03 - Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
- This funding opportunity was created on 2021-11-09.
- Applicants must submit their applications by 2024-11-16. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $50,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: NIH PAR-21-354 - Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R03 - Clinical Trial Optional)
What is the NIH funding opportunity PAR-21-354?
PAR-21-354 is an NIH funding opportunity titled "Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R03 - Clinical Trial Optional)." It supports early-stage, small-scope research projects focused on improving how serious conditions are identified and treated in newborns, especially in the context of newborn screening.
What is the main goal of this opportunity?
The main goal is to encourage practical, testable advances that strengthen newborn screening and the actions that follow screening. This includes (1) developing or improving screening approaches and (2) advancing therapeutic interventions tied to newborn screening, particularly by building evidence that early treatment improves outcomes.
What types of disorders are in scope for this FOA?
The FOA focuses on disorders already identified through newborn screening programs, as well as "high priority" genetic conditions that are not currently recommended for routine screening but may be feasible to screen for in the near future.
What does "high priority" mean in this announcement?
In this FOA, a "high priority" condition is one where early detection would meaningfully change outcomes because infants would significantly benefit from prompt identification and early treatment, even though the condition is not currently on standard screening panels.
What kinds of screening projects does NIH appear to be looking for?
Screening-focused projects may include creating or refining tests that are more accurate, faster, more scalable for public health laboratories, or better at reducing false positives and false negatives. The emphasis is on improvements that make screening more reliable and practical for real-world use.
What kinds of therapy or intervention projects fit this opportunity?
Therapy-focused projects are intended to strengthen the evidence that early intervention improves health outcomes in newborns. The FOA is looking for studies that help demonstrate that acting on early screening results can prevent death, disability, or irreversible disease progression.
Why does NIH emphasize evidence for early treatment benefit?
The opportunity highlights that showing a clear benefit from early detection and treatment is a key consideration when deciding whether a condition should be added to a newborn screening panel. The program is aimed at closing the gap between detecting a condition and proving that early action makes a meaningful difference in outcomes.
What grant mechanism is used (R03), and what does that imply?
This opportunity uses the R03 mechanism, which is typically used for pilot or feasibility research, proof-of-concept studies, and other discrete projects that can be completed with limited resources. It is geared toward focused, well-defined aims rather than large, multi-year development programs.
What is the funding cap or award ceiling mentioned?
The listed award ceiling is $50,000, indicating the FOA is designed for small-scope work with limited budgets and targeted objectives.
Is a clinical trial required to apply?
No. The FOA is labeled "clinical trial optional," meaning applicants may propose a study that includes a clinical trial component if it fits the aims, but a clinical trial is not required.
What does "clinical trial optional" mean in practice for this FOA?
It means proposed projects can be either non-clinical-trial studies or studies that include a clinical trial component, as long as the work supports the goals of improving newborn screening approaches and/or therapies connected to newborn screening.
Who is eligible to apply for PAR-21-354?
A broad range of organizations are eligible, including various levels of government (state, county, city/township, special districts), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized Native American tribal governments, and tribal organizations that are not federally recognized.
Are nonprofits eligible, and do they need 501(c)(3) status?
Nonprofits are eligible whether or not they have 501(c)(3) status, based on the eligibility information provided.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) and small businesses are listed as eligible applicants.
Are institutions serving specific communities explicitly included as eligible?
Yes. The FOA explicitly highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly listed among the eligible applicant types.
Can federal agencies apply?
Yes. Eligible federal agencies are included among the eligible applicant types in the information provided.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are explicitly included as eligible applicants.
Are non-U.S. (foreign) organizations eligible?
Yes. The opportunity includes non-U.S. entities (foreign organizations) as eligible applicants.
What is the assistance listing (CFDA) number for this opportunity?
The NIH assistance listing (CFDA) number provided is 93.865.
How is this opportunity categorized?
It is categorized as a discretionary grant within the health and social services activity area.
What is the closing date listed in the provided information?
The original closing date listed is 2024-11-16.
When was this opportunity created?
The opportunity creation date listed is 2021-11-09.
Does the summary specify the expected number of awards?
No. The summary information provided does not specify the expected number of awards.
What overall outcome is NIH trying to move forward with this program?
NIH is aiming to move forward practical advances that help newborn screening programs by improving reliable detection and building strong proof that early action improves infants' outcomes. In other words, work that helps conditions meet real-world screening criteria: accurate, scalable detection plus evidence that early intervention prevents serious harm.
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